Data exclusivity for biologics

Grabowski, Henry G.; Long, Genia; Mortimer, Richard

doi:10.1038/nrd3277

Cited by 18 publications

(11 citation statements)

References 5 publications

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“…This report is discussed in Berndt and Aitken (2011). 6. An analysis of the relationship between data exclusivity time and innovation incentives is provided in Grabowski (2008) and Grabowski et al (2011a). 7.…”

Section: Am Indebted To Many Individuals For Sparking My Interests mentioning

confidence: 99%

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

Grabowski

2011

International Journal of the Economics of Business

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The pharmaceutical industry has an outstanding record of innovative performance over the past 50 years. The R&D process has become more knowledge-based and a market for innovation has emerged between research start-ups, development-stage firms, and the larger, multinational companies. At the same time, R&D costs have increased several fold over time and generic products now dominate many traditional therapeutic areas. The current challenge for the industry is to discover new therapies for chronic diseases with high unmet needs like Alzheimer's disease and various auto-immune diseases and cancers that afflict an increasingly aging population. Recent advances in molecular biology and related fields provide a scientific foundation to undertake these R&D efforts, although the time path and outcomes remain subject to many risks and uncertainties.Pharmaceuticals, Innovation, R&D, Biotechnology, Generics, Alliances,

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Section: Am Indebted To Many Individuals For Sparking My Interests mentioning

confidence: 99%

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

Grabowski

2011

International Journal of the Economics of Business

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“…Importantly, for biological products, PPACA established a period of 12 years for data exclusivity, which is the time between original FDA approval and generic filing. This is in contrast to the period for conventional drugs, which is 5 years for a New Drug Application or 3 years following a New Drug Indication . As a recombinant therapeutic protein, rituximab antibody therapy received its first FDA approval through CBER in 1997 for relapsed or refractory, CD20+, B cell, low‐grade NHL.…”

Section: Fda Approval Processmentioning

confidence: 99%

Rituximab for Non‐Hodgkin's Lymphoma: A Story of Rapid Success in Translation

Harrison

Thalji

Greenberg

et al. 2013

Clinical Translational Sci

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Translational stories range from straightforward to complex. In this commentary, the story of the rapid and successful translation of rituximab therapy for the treatment of non-Hodgkin’s lymphoma (NHL) is examined. Development of this monoclonal antibody therapy began in the late 1980s. In 1994, rituximab received its first approval for the treatment of NHL by the United States Food and Drug Administration (FDA). Rituximab has since been approved for additional indications and has transformed medical practice. However, the social and political implications of these rapid successes are only beginning to become clear. In this commentary, key events in the rapid translation of rituximab from the bench to bedside are highlighted and placed into this historical framework. To accomplish this, the story of rituximab is divided into the following six topics, which we believe to be widely applicable to case studies of translation: (1) underlying disease, (2) key basic science, (3) key clinical studies in translation, (4) FDA approval process, (5) changes to medical practice, and (6) the social and political influences on translation.

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“…On the occasion of approval of the innovator biologic by the regulatory agencies, its manufacturer receives data exclusivity, a back‐up to the patent system, to delay abbreviated applications for biosimilars and patent challenges by competitors. The data exclusivity for biologics in the EU is the same for chemical products, 10 years, and one additional year when an important new indication is established . Biosimilar approval in the US is significantly different from the EU and generic drugs under the Hatch‐Waxman Amendments considering data exclusivity and patent challenges, delaying the approval of biosimilars.…”

Section: Regulatory Aspectsmentioning

confidence: 99%

“…The data exclusivity for biologics in the EU is the same for chemical products, 10 years, and one additional year when an important new indication is established. 33 Biosimilar approval in the US is significantly different from the EU and generic drugs under the Hatch-Waxman Amendments considering data exclusivity and patent challenges, delaying the approval of biosimilars. According to BPCI Act, the reference product receives 12 years of data exclusivity plus 6 months if pediatric studies were conducted.…”

Section: Anvisa (Agência De Vigilânciamentioning

confidence: 99%

Biosimilars advancements: Moving on to the future

Tsuruta

Santos

Moro

2015

Biotechnol Progress

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in Wiley Online Library (wileyonlinelibrary.com) Many patents for the first biologicals derived from recombinant technology and, more recently, monoclonal antibodies (mAbs) are expiring. Naturally, biosimilars are becoming an increasingly important area of interest for the pharmaceutical industry worldwide, not only for emergent countries that need to import biologic products. This review shows the evolution of biosimilar development regarding regulatory, manufacturing bioprocess, comparability, and marketing. The regulatory landscape is evolving globally, whereas analytical structure and functional analyses provide the foundation of a biosimilar development program. The challenges to develop and demonstrate biosimilarity should overcome the inherent differences in the bioprocess manufacturing and physicochemical and biological characterization of a biosimilar compared to several lots of the reference product. The implementation of approaches, such as Quality by Design (QbD), will provide products with defined specifications in relation to quality, purity, safety, and efficacy that were not possible when the reference product was developed. Actually, the need to prove comparability to the reference product by the biosimilar industry has increased the knowledge about the product and the production-process associated by the use of powerful analytical tools. The technological challenges to make copies of biologic products while attending regulatory and market demands are expected to help innovation in the direction of attaining more productive manufacturing processes.

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Data exclusivity for biologics

Cited by 18 publications

References 5 publications

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

Rituximab for Non‐Hodgkin's Lymphoma: A Story of Rapid Success in Translation

Biosimilars advancements: Moving on to the future

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